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April 23, 2014
New Therapy Produces High HCV Cure Rates for Patients
With Cirrhosis

San Antonio, TX—More than 90% of liver cirrhosis patients were cured of hepatitis C with a novel combination therapy, according to a new study which noted that historical cure rates have been lower than 50%.

In addition, the therapy was well-tolerated by patients with cirrhosis, unlike past treatments, according to the study published online recently in the New England Journal of Medicine simultaneous with presentation at the International Liver Congress in London.

Lead author Fred Poordad, MD, of the University of Texas San Antonio and the Texas Liver Institute, noted that hepatitis C virus (HCV) is the leading cause of cirrhosis, liver transplants, and liver cancer in the U.S.

Previously, according to the study, interferon was the only agent to show effectiveness against hepatitis C, but patients often relapsed and the therapy caused multiple side effects. The new regimen is interferon-free and consists of several agents—ABT-450/ritonavir, ombitasvir, dasabuvir, and ribavirin.

Twelve weeks after the last dose, no hepatitis C virus was detected in the bloodstream of 91.8% of patients on the new regimen, and, among patients treated for 24 weeks, 95.9% were virus-free 12 weeks after the end of therapy, according to the study.

“These are out-of-the-ballpark response rates, not on the same planet as interferon,” Poordad said. “The reason this study is so profound is because interferon is not tolerated nor is it safe in many people with cirrhosis. Many of the patients with cirrhosis in this study were not even eligible to be treated with interferon.”

The study, supported by biopharmaceutical company AbbVie, examined outcomes in 380 patients at 78 sites, including hospitals and centers in Spain, Germany, England, Canada, and the United States.

“In conclusion, this multitargeted approach combining ritonavir-enhanced ABT-450 with ombitasvir, dasabuvir, and ribavirin resulted in rates of sustained virologic response at post-treatment week 12 of 92% with a 12-week regimen and 96% with a 24-week regimen, with a low rate of treatment discontinuation, among both previously untreated and previously treated patients with HCV genotype 1 infection and compensated cirrhosis, a group at risk for liver-related illness and death,” the authors report.

Investigators are cataloging patient blood samples for 3 years after therapy and, thus far, have noticed no long-term, late relapses, Poordad said. “Patients with advanced liver disease can now be cured of their hepatitis with a very well-tolerated and short regimen,” he added.

The combination therapy is expected to be on the market as early as the end of 2014 or very early 2015.





U.S. Pharmacist Social Connect